Orgalutran
ganirelix
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Orgalutran. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Orgalutran.
Authorisation details
Product details | |
---|---|
Name |
Orgalutran
|
Agency product number |
EMEA/H/C/000274
|
Active substance |
ganirelix
|
International non-proprietary name (INN) or common name |
ganirelix
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
H01CC01
|
Publication details | |
---|---|
Marketing-authorisation holder |
N.V. Organon
|
Revision |
24
|
Date of issue of marketing authorisation valid throughout the European Union |
16/05/2000
|
Contact address |
Kloosterstraat 6 |
Product information
20/03/2023 Orgalutran - EMEA/H/C/000274 - N/0056
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Pituitary and hypothalamic hormones and analogues
Therapeutic indication
The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques.
In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.